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Completed

NCT Number: NCT05402982

Intraoperative Fluid Management of Liposuction , Cardiometry Versus Rohrich Formula

The aim of the study is to compare the hemodynamic parameters of fluid resuscitation using Rohrich formula to cardiometry guided stroke volume variation in patients undergoing large volume liposuction surgery .

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Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, Gharbia Governorate, Egypt

About this study

The study will done on 50 patients divided equally into two groups. Group A Fluid administration in the form of lactated ringer will be managed by Rohrich formula and the intraoperative fluid ratio (subcutaneous infiltration fluid plus intravenous fluid divided by total aspirate volume) will be 1.2. Rohrich formula represents fluid maintenance,deficit and replacement fluid ( 0.25 ml crystalloid given for each 1 ml above 4 litre of lipoaspirate).

Group B Patients will receive fluid maintenance of lactated ringer 2 ml/kg/h, cardiometry guided stroke volume variation will be measured before and after induction then every 30 min ,it ranges between 5-15%, fluid bolus of lactated ringer 4 ml /kg over 15 min will be administered if stroke volume variation ˃ 15% .

Electrical cardiometry will be connected to the patient before induction,the skin will be clean and dry before placing the electrodes. Four electrodes will be applied, first one is at the upper part of the anterior aspect of the neck, second one is 5 cm below the first electrode at lower part of the neck, third one at the lower left thorax in line with xiphoid process at the level of anterior axillary line and the fourth one is 5 cm below the third electrode at the level of anterior axillary line.Electrical cardiometry will be connected to the sensor cable and the patient data will be applied as (gender - age - height - weight - blood pressure -heart rate - hemoglobin and oxygen saturation).

Surgical Technique The wetting solution will be lactated ringer with epinephrine 1mg on 1 litre so concentration is 1:1,000,000.10 ml lidocaine 2% will be added.Subcutaneous infiltration of the wetting solution will facillate dissection and removal of fat ,the technique that will be used is traditional liposuction , suction assisted liposuction with super wet technique ( the amount of infiltration solution is equal to the amount of fat aspirate).

The liposuction cannula is a multihole blunt tip cannula with a diameter of 3 to 6 mm, 4-6 mm for deep liposuction,2-4 mm for superficial liposuction and a length ranging between 10 to 30 cm. The surgeon will inject the wetting solution to the target area until it becomes tense then infiltrates the other side waiting 10 to 15 min after infiltration to begin suction .The aspirate will be collected in suction container, fat will separate from solution after approximately 1-2 h by gravity into upper yellowish part includes fat called supernatant and lower part includes blood tinged fluid called infranatant.

Measurements

  • Noninvasive blood pressure ,oxygen saturation, Heart rate before induction, 5 min and 15 min after induction then every 30 min.
  • Urine output, baseline and every hour.
  • Venous blood sample for measurement of hemoglobin and hematocrit level after aspiration of 4 litre of fat and for every litre after.
  • Measurement of blood volume in aspirate by taking a sample from infranatant part after its separation from fat for hemoglobin level calculation and by equation of multiplying this hemoglobin concentration to infranatant volume divided by preoperative hemoglobin concentration, the investigators can measure blood volume in aspirate .
  • Amount of intravenous and infiltration fluids.
  • Amount of fat and total aspirate.
  • Stroke volume variation before and after induction then every 30 min.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female patients aged between 21 to 60 years.
  • American Society of Anesthesiologists (ASA) Ӏ& ӀӀ.
  • Large volume liposuction.

Exclusion criteria

  • Any bleeding& coagulation disorders.
  • Patients on regular anticoagulant or antiplatelet drugs.
  • History of previous surgery in treated areas.
  • Significant cardiopulmonary, hepatic or renal disease.

Treatment and study plan

Electrical Cardiometry (EC) ICON

Device

Electrical Cardiometry (EC) ICON (Osypka Medical, Berlin, Germany) is an FDA approved device used for non-invasive measurement of some hemodynamic parameters as cardiac output,cardiac index, stroke volume,stroke volume variation, systemic vascular resistance, thoracic fluid content, ICON (index of contractility), variation of ICON,corrected flow time and systolic time ratio.The set data of EC are the height, weight,hemoglobin, Oxygen saturation(SPO2),age, gender ,blood pressure and heart rate(HR) of the patient

Rohrich formula

Other

Rohrich formula and the intraoperative fluid ratio (subcutaneous infiltration fluid plus intravenous fluid divided by total aspirate volume) will be 1.2

Primary outcomes

  1. Mean arterial blood pressure

    Time frame: 1 year

    Mean arterial blood pressure at 4 litre aspiration of fat and at every litre aspirated after.

Secondary outcomes

  1. blood loss

    Time frame: 1 year

    estimation of blood loss by venous sample and suction sample

  2. urine output

    Time frame: 1 year

    detection of tissue perfusion by urine output every hour

Sponsors and collaborators

Lead sponsor

Ahmed Abdel Wahed Ali

Other

Collaborators

  • Tanta University

Registry information

Official study title

Intraoperative Fluid Management of Large Volume Liposuction Surgery , Cardiometry Guided Stroke Volume Variation Versus Rohrich Formula

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 2, 2022
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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